Vigantol oil solution 10ml №1

Description:

Description of the active substance (INN):

Colecalciferol

Dosage form

oral drops, capsules, oral solution [oil], tablets

Pharmachologic effect:

A means to compensate for the deficiency of vitamin D3. Participates in the regulation of calcium-phosphorus metabolism, enhances the absorption of Ca2 + and phosphates in the intestine (due to an increase in the permeability of the cellular and mitochondrial membranes of the intestinal epithelium) and their reabsorption in the renal tubules of the kidneys; promotes bone mineralization, the formation of the bone skeleton and teeth in children, strengthens the ossification process, is necessary for the normal functioning of the parathyroid glands. Vitamin D3 is formed in the skin under the influence of UV rays from provitamin 7-dehydrocholesterol. In order to maintain normal levels of vitamin D in the serum, only sunlight of the skin of the face and hands of the child 2 hours per week is sufficient, and the mother’s UV radiation (1.5 minimum erythemal doses to the whole body for 90 seconds) increases the amount of vitamin D3 in her milk 10 times.

Indications and usage

Vitamin D hypo and vitamin D avitaminosis (prophylaxis and treatment), the state of increased body need for vitamin D: rickets, osteomalacia, osteoporosis, nephrogenic osteopathy, inadequate and unbalanced nutrition (includingparenteral, vegetarian diet), malabsorption syndrome, insufficient insolation, hypocalcemia, hypophosphatemia (including familial), alcoholism, hepatic insufficiency, cirrhosis, obstructive jaundice, gastrointestinal diseases (gluteic enteropathy, persistent diarrhea, tropical sphroma, disease, illness, gastrointestinal tract, illness of the gastrointestinal rapid weight loss, pregnancy (especially with nicotine and drug addiction, multiple pregnancies), lactation period; breastfed newborns with insufficient insolation; taking barbiturates, colestiramine, colestipol, mineral oils, anticonvulsants (including phenytoin and primidone). Hypoparathyroidism: postoperative, idiopathic, tetany (postoperative and idiopathic), pseudohypoparathyroidism.

Contraindications:

Hypersensitivity, hypercalcemia, hypervitaminosis D, renal osteodystrophy with hyperphosphatemia. C caution. Atherosclerosis, sarcoidosis or other granulomatosis, CHF, history of nephrorolithiasis, hyperphosphatemia, chronic renal failure, pregnancy, lactation, childhood.

Adverse reactions

Allergic reactions. Hypercalcemia, hypercalciuria; loss of appetite, polyuria, constipation, headache, myalgia, arthralgia, increased blood pressure, arrhythmias, impaired renal function, exacerbation of the tuberculous process in the lungs. Overdose. Vitamin D hypervitaminosis symptoms: early (caused by hypercalcemia) - constipation or diarrhea, dryness of the oral mucosa, headache, thirst, pollakiuria,nocturia, polyuria, anorexia, metallic taste in the mouth, nausea, vomiting, extreme tiredness, weakness, hypercalcemia, hypercalciuria; late - pain in the bones, turbidity of the urine (appearance of hyaline cylinders in the urine, proteinuria, leukocyturia), increased blood pressure, pruritus, eye photosensitivity, conjunctival hyperemia, arrhythmia, drowsiness, myalgia, nausea, vomiting, pancreatitis, gastralgia, weight loss, changes in the psyche (up to the development of psychosis) and mood. Symptoms of chronic intoxication with vitamin D (when taken for several weeks or months for adults in doses of 20-60 thousand IU / day, children - 2-4 thousand IU / day): calcification of soft tissues, kidneys, lungs, blood vessels, arterial hypertension, renal and cardiovascular insufficiency up to death (these effects most often occur when hyperphosphatemia is associated with hypercalcemia), growth impairment in children (long-term use at a dose of 1.8 thousand IU / day). Treatment: removal of the drug, a diet low in Ca2 +, consumption of large quantities of fluid, the appointment of GCS, alpha-tocopherol, Ascorbic acid, Retinol, thiamine, in severe cases - in / in the introduction of large amounts of 0.9% NaCl solution, Furosemide, electrolytes, carrying hemodialysis.

Dosage and administration

Inside or in / m, for the prevention of rickets - in a dose of 200 thousand IU (5 mg) 1 time in 6 months (up to 5 years). If a child is rarely in the sun or his skin is hyperemic, a single dose is increased to 400 thousand IU, also administered once every six months (up to 5 years). Treatment of rickets, spasmophilia and hypocalcemia - 200 thousand IU once a week for 2 weeks (in combination with Ca2 + drugs).To prevent attacks of tetany - up to 1 million IU / day. With osteomalacia and osteoporosis - 200 thousand IU every 15 days for 3 months. Drops for oral administration (1 cap = 500 IU): for the prevention of rickets in infants (full-term), starting at 2 weeks of age, - daily, 500 IU / day; in special cases (for example, premature babies) - up to 1000 IU / day with preterm I Art. and 1000-2000 IU / day) for preterm II and III Art. (excluding summer months); for the treatment of rickets - 2000-5000 IU / day in 2-3 doses for 1-1.5 months, then transferred to maintenance therapy - 500 IU / day) for 2 years and in the winter period at 3 years of age. A dose of 5000 IU is prescribed only for pronounced bone changes. 3 months after the end of the 1st course, children from the risk group are given a repeated course of anti-relapse treatment of 2,000–5,000 IU / day for 3–4 weeks, with the exception of the summer months. Infants with spasmophilia - 5000 IU 3 times a day. Adults for the prevention of osteomalacia - 500-1000 IU 3 times a day, for the treatment of osteomalacia - up to 2500 IU 3 times a day. In hypoparathyroidism and pseudohypoparathyroidism - 7500-15000 IU / day. At the same time, it is necessary to control the concentration of Ca2 + in the blood every 3-6 months and, if necessary, adjust the dosage regimen.

Special notes

The daily need for vitamin D3 for adults is 400 IU (10 μg). Apply blood and urine concentrations of Ca2 + under medical supervision (especially when combined with thiazide diuretics). With prophylactic use, you must keep in mind the possibility of overdose, especially in children (you should not prescribe more than 10-15 mg per year).Prolonged use in high doses leads to chronic hypervitaminosis D3. It should be borne in mind that sensitivity to vitamin D in different patients is individual and in some patients even therapeutic doses may cause hypervitaminosis. The sensitivity of newborns to vitamin D may be different, some of them may be sensitive even to very low doses. Children who receive vitamin D for a long period of time increase the risk of stunting. For the prevention of hypovitaminosis D, most preferably a balanced diet. Breast-fed newborns, especially those born to dark-skinned mothers and / or who have not received enough insolation, are at high risk of vitamin D deficiency. In animal experiments, calcitriol was shown in doses 4-15 times higher than the recommended doses for humans. has a teratogenic effect. Maternal hypercalcemia (associated with prolonged overdose of vitamin D during pregnancy) may cause an increase in the sensitivity of the fetus to vitamin D, parathyroid function suppression, specific elf-like appearance syndrome, mental retardation, aortic stenosis. In old age, the need for vitamin D may increase due to a decrease in the absorption of vitamin D, a decrease in the ability of the skin to synthesize pro-vitamin D3, a decrease in the insolation time, and an increase in the incidence of renal failure.

Drug interactions

Vitamin A, tocopherol, ascorbic acid, pantothenic acid, thiamine, riboflavin weaken the toxic effect. In hypervitaminosis D, the effect of cardiac glycosides may be enhanced and the risk of arrhythmia may increase due to the development of hypercalcemia (a dose adjustment of cardiac glycoside is appropriate). Under the influence of barbiturates (including phenobarbital), phenytoin and primidone, the need for co-calciferol can increase significantly (increase the metabolic rate). Long-term therapy against the background of the simultaneous use of Al3 + and Mg2 + -containing antacids increases their concentration in the blood and the risk of intoxication (especially in the presence of CRF). Calcitonin, derivatives of etidronic and pamidronic acids, plicamycin, gallium nitrate and corticosteroids reduce the effect. Kolestiramine, Kolestipol and mineral oils reduce the absorption of fat-soluble Vitamins in the gastrointestinal tract and require increasing their dosage. Increases the absorption of phosphorus-containing drugs and the risk of hyperphosphatemia. With simultaneous use of sodium fluoride, the interval between intake should be at least 2 hours; with oral forms of tetracyclines - not less than 3 hours. Simultaneous use with other analogues of vitamin D increases the risk of developing hypervitaminosis.